Sens. Richard Burr (R-NC), Michael Bennett (D-CO) and Orrin Hatch (R-UT) joined together last week in presenting bipartisan legislation to streamline the process for bringing breakthrough medical devices to the front line where patients can enjoy their benefits as quickly as possible.
“America is the world’s most innovative nation, especially in our medical research and development,” Burr said. “America’s patients deserve access to the latest, most cutting-edge life-saving therapies and devices, and we need to advance these innovative medical products, including breakthrough devices. (The Food and Drug Administration) FDA can be a key partner in this important endeavor.”
The bill builds upon the Advancing Breakthrough Therapies for Patients Act, introduced by the same trio of senators in 2012. As with its predecessor, the new bill employs an “all hands-on-deck” approach to devices, while at the same time complementing and enhancing tools already in place with the objective of expediting the development and review of breakthrough medical products.
“Americans ought to benefit from the latest life-saving research and innovative devices developed by the medical community, and this measure ensures FDA can give a helping hand,” Hatch said. “By streamlining the approval process and improving regulatory certainty, we’re giving more patients a fighting chance to improve their lives.”
Bennett said medical innovation helps drive his state’s economy and is improving the lives of patients across the U.S.
“This bill helps create a system that will spur this type of innovation and ensure patients have access to potentially lifesaving breakthrough medical devices,” he said. “It complements the highly successful Breakthrough Therapies program we passed with the help of Sens. Burr and Hatch by streamlining the review process and ensuring the most effective and safe devices are helping patients.”